Arteriovenous fistulae remain the access of choice for most hemodialysis patients. However, several factors limit their uptake and long-term patency, resulting in suboptimal prevalent rates in many ...high-income countries. Patients place considerable value on the avoidance of vascular access complications, pain and disfigurement. The approach to cannulation is a modifiable practice that could improve patient-important outcomes, with buttonhole needling offering some theoretical advantages over the standard rope-ladder and area methods. In this narrative review, we summarize key findings of studies reporting the benefits and risks associated with the buttonhole method, highlighting methodological limitations as well as recent refinements to the technique that may represent potential opportunities for reducing infection risk. We highlight the need for greater certainty surrounding the potential benefits of the buttonhole cannulation technique and propose some directions for future research.
While home dialysis is being promoted, there are few comparative effectiveness studies of home-based modalities to guide patient decisions. To address this, we matched 1116 daily home hemodialysis ...(DHD) patients by propensity scores to 2784 contemporaneous USRDS patients receiving home peritoneal dialysis (PD), and compared hospitalization rates from cardiovascular, infectious, access-related or bleeding causes (prespecified composite), and modality failure risk. We performed similar analyses for 1187 DHD patients matched to 3173 USRDS patients receiving in-center conventional hemodialysis (CHD). The composite hospitalization rate was significantly lower with DHD than with PD (0.93 vs. 1.35/patient-year, hazard ratio=0.73 (95% CI=0.67–0.79)). DHD patients spent significantly fewer days in hospital than PD patients (5.2 vs. 9.2 days/patient-year), and significantly more DHD patients remained admission-free (52% DHD vs. 32% PD). In contrast, there was no significant difference in hospitalizations between DHD and CHD (DHD vs. CHD: 0.93 vs. 1.10/patient-year, hazard ratio 0.92 (0.85–1.00)). Cardiovascular hospitalizations were lower with DHD than with CHD (0.68 (0.61–0.77)), while infectious and access hospitalizations were higher (1.15 (1.04–1.29) and 1.25 (1.08–1.43), respectively). Significantly more PD than DHD patients switched back to in-center HD (44% vs. 15%; 3.4 (2.9–4.0)). In this prevalent cohort, home DHD was associated with fewer admissions and hospital days than PD, and a substantially lower risk of modality failure.
AbstractObjectiveTo develop an instrument to evaluate the credibility of anchor based minimal important differences (MIDs) for outcome measures reported by patients, and to assess the reliability of ...the instrument.DesignInstrument development and reliability study.Data sourcesInitial criteria were developed for evaluating the credibility of anchor based MIDs based on a literature review (Medline, Embase, CINAHL, and PsycInfo databases) and the experience of the authors in the methodology for estimation of MIDs. Iterative discussions by the team and pilot testing with experts and potential users facilitated the development of the final instrument.ParticipantsWith the newly developed instrument, pairs of masters, doctoral, or postdoctoral students with a background in health research methodology independently evaluated the credibility of a sample of MID estimates.Main outcome measuresCore credibility criteria applicable to all anchor types, additional criteria for transition rating anchors, and inter-rater reliability coefficients were determined.ResultsThe credibility instrument has five core criteria: the anchor is rated by the patient; the anchor is interpretable and relevant to the patient; the MID estimate is precise; the correlation between the anchor and the outcome measure reported by the patient is satisfactory; and the authors select a threshold on the anchor that reflects a small but important difference. The additional criteria for transition rating anchors are: the time elapsed between baseline and follow-up measurement for estimation of the MID is optimal; and the correlations of the transition rating with the baseline, follow-up, and change score in the patient reported outcome measures are satisfactory. Inter-rater reliability coefficients (ĸ) for the core criteria and for one item from the additional criteria ranged from 0.70 to 0.94. Reporting issues prevented the evaluation of the reliability of the three other additional criteria for the transition rating anchors.ConclusionsResearchers, clinicians, and healthcare policy decision makers can consider using this instrument to evaluate the design, conduct, and analysis of studies estimating anchor based minimal important differences.
Prior guidelines were based on observational studies that were prone to confounding by indica- tion (i.e., patients who had earlier initiation of dial- ysis may have been in poorer health with a ...worse prognosis than those who started dialysis later) and cannot provide accurate estimates of the benefits and harms associated with starting dialysis early versus late. The IDEAL study compared early ver- sus late initiation of dialysis, based on estimated creatinine clearance (eCrCl) thresholds (10-14 v. 5-7 mL/min per 1.73 m2) as estimated by the Cockroft-Gault formula.6 Patients randomly assigned to the group receiving late initiation of dialysis could cross over to an earlier initiation based on clinical symptoms and other complica- tions of advanced chronic kidney disease. For the purposes of this guideline, we defined this as an "intent-to-defer" approach to dialysis initiation. Similarly, patients randomly assigned to an early start could cross over to a later start; this was termed an "intent-to-start-early" strategy. In the IDEAL study, the researchers found a difference in eCrCl of 2.2 mL/min between the intent-to-defer and intent-to-start-early groups. The intent-to-defer strategy resulted in a cross- over rate of 75%, and a mean eCrCl of 9.8 mL/ min (MDRD eGFR 7.2 mL/min) at dialysis in- itiation. There was also a 19% crossover rate among patients in the intent-to-start-early group, resultin g in a mean eCrCl of 12.0 mL/mi n (MDRD eGFR 9.0 mL/min) at dialysis initia- tion.17 Despite adequate power, there was no sta- tistically significant difference in survival (haz- ard ratio HR 1.04, 95% confidence interval CI 0.83-1.30) with the intent-to-start-early ver- sus intent-to-defer groups, using intent-to-treat analysis.6 The recently published systematic review of survival outcomes found a similar result in the pooled analysis of 15 observational studies (HR 1.04, 95% CI 1.03-1.05).19 Importantly, however, no published clinical trials have studied the effects of deferring dialysis beyond the threshold of 5-7 mL/min per 1.73 m2 (eGFR ≤ 6 mL/min per 1.73 m2). In the IDEAL study, all patients who remained in the intent-to- defer group initiated dialysis when the eCrCl reached 5-7 mL/min, regardless of whether they had symptoms. We therefore consider an MDRD eGFR range of 6 mL/min per 1.73 m2 or less a reasonable lower threshold for the intent-to-defer strategy in a Canadian population. Hence, it seems prudent to initiate dialysis once this thresh- old is reached, based on this uncertainty and to reduce the risk of emergent dialysis.
Abstract Objective We evaluated the inter-rater reliability (IRR) of assessing the quality of evidence (QoE) using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) ...approach. Study Design and Setting On completing two training exercises, participants worked independently as individual raters to assess the QoE of 16 outcomes. After recording their initial impression using a global rating, raters graded the QoE following the GRADE approach. Subsequently, randomly paired raters submitted a consensus rating. Results The IRR without using the GRADE approach for two individual raters was 0.31 (95% confidence interval 95% CI = 0.21–0.42) among Health Research Methodology students ( n = 10) and 0.27 (95% CI = 0.19–0.37) among the GRADE working group members ( n = 15). The corresponding IRR of the GRADE approach in assessing the QoE was significantly higher, that is, 0.66 (95% CI = 0.56–0.75) and 0.72 (95% CI = 0.61–0.79), respectively. The IRR further increased for three (0.80 95% CI = 0.73–0.86 and 0.74 95% CI = 0.65–0.81) or four raters (0.84 95% CI = 0.78–0.89 and 0.79 95% CI = 0.71–0.85). The IRR did not improve when QoE was assessed through a consensus rating. Conclusion Our findings suggest that trained individuals using the GRADE approach improves reliability in comparison to intuitive judgments about the QoE and that two individual raters can reliably assess the QoE using the GRADE system.
Background:
Medium cut-off (MCO) membranes enhance large middle-molecule clearance while selectively retaining molecules >45 000 Da.
Objectives:
We undertook a systematic review and meta-analysis ...comparing the effects of MCO versus high-flux membranes on biomarkers.
Methods:
We searched MEDLINE, Embase, CINAHL, Cochrane Library, and Web of Science from January 2015 to July 2020, and gray literature sources from 2017. We included randomized (RS) and nonrandomized studies (NRS) comparing MCO and high-flux membranes in adults (>18 years) receiving maintenance hemodialysis. We performed study selection, data extraction, and quality appraisals in duplicate and used the Grading of Recommendations Assessment, Development, and Evaluation framework. Outcomes included solute removal (plasma clearance or dialysate quantitation), reduction ratios, and predialysis serum concentrations for a range of prespecified large middle molecules.
Results:
We identified 26 eligible studies (10 RS and 16 NRS; N = 1883 patients; patient-years = 1366.3). The mean difference (MD) for albumin removal was 2.31 g per session (95% confidence interval CI, 2.79 to 1.83; high certainty), with a reduction in predialysis albumin of −0.12 g/dl (95% CI, −0.16 to −0.07; I2 = 0%; high certainty) in the first 24 weeks, returning to normal (MD = −0.02 g/dl, 95% CI, −0.07 to −0.03; I2 = 56%; high certainty) after 24 weeks. We also found with high certainty that MCO dialysis resulted in a large increase (standardized mean difference SMD> 2.0 for all) in β2-microglobulin, κ- and λ-free light chains, and myoglobin removal, resulting in moderate (SMD > 0.5) to large (SMD > 0.8) reductions in predialysis concentrations for all of these solutes. Medium cut-off dialysis increased the reduction ratio for tumor necrosis factor-alpha (TNF-α) by 7.7% (95% CI, 4.7 to 10.6; moderate certainty), and reduced predialysis TNF-α by SMD −0.48 (95% CI, −0.91 to −0.04; moderate certainty). We found with moderate certainty that MCO dialysis had little to no effect on predialysis interleukin-6 (IL-6) plasma concentrations. Medium cut-off dialysis reduced mRNA expression of TNF-α and IL-6 in peripheral leukocytes by MD −15% (95% CI, −19.6 to −10.4; moderate certainty) and −8.8% (95% CI, −10.2 to −7.4; moderate certainty), respectively.
Conclusion:
Medium cut-off dialysis increases the clearance of a wide range of large middle molecules and likely reduces inflammatory mediators with a concomitant transient reduction in serum albumin concentration. The net effect of MCO dialysis on large middle molecules could translate into important clinical effects.
Background:
A novel medium cut-off (MCO) dialyzer (Theranova, Baxter Healthcare, Deerfield, IL, USA) enhances large middle molecule clearance while retaining selectivity for molecules >45 000 Da.
...Objective:
We undertook a systematic review and meta-analysis evaluating clinical outcomes with MCO vs high-flux membranes.
Methods:
We searched MEDLINE, EMBASE, CINAHL, Cochrane Library, and Web of Science through July 2020, and gray literature sources from 2017. We included randomized (RS) and nonrandomized studies (NRS) comparing MCO and high-flux membranes in adults receiving maintenance hemodialysis. Pairs of reviewers performed study selection, data extraction, and risk of bias assessment in duplicate. We conducted random-effects pairwise meta-analyses to pool results across studies and used the Grading of Recommendations Assessment, Development and Evaluation approach to assess evidence certainty.
Results:
We identified 22 eligible studies (6 RS, 16 NRS; N = 1811 patients; patient-years = 1546). The MCO dialyzer improved (estimate; 95% confidence interval CI; certainty rating) quality of life (mean difference MD = 16.7/100 points; 6.9 to 26.4; moderate), Kidney Disease Quality of Life Instrument (KDQOL) subscales—burden (MD = 4.0; 1.1 to 6.9; moderate) and effects (MD = 5.4; 3.2 to 7.6; moderate), pruritus (MD = −4.4; −7.1 to −1.7; moderate), recovery time (MD = −420 minutes; −541 to −299; high), and restless legs syndrome (odds ratio = 0.39; 0.29 to 0.53; moderate). There was little to no difference in all-cause mortality (risk difference = −0.4%; −2.8 to 2.1; moderate) and serious adverse events (rate ratio = 0.63; 0.38 to 1.04; low). MCO dialysis reduced hospitalization (rate ratio = 0.48; 0.27 to 0.84; low), infection (rate ratio = 0.38; 0.17 to 0.85; moderate), hospitalization days (MD = −1.5 days; 95% CI, −2.22 to −0.78; moderate), erythropoiesis resistance index (MD = −2.92 U/kg/week/g/L; 95% CI, −4.25 to −1.6; moderate) and cumulative iron use over 12 weeks (MD = −293 mg; 95% CI, −368 to −218; moderate). We found with low certainty that MCO dialysis had little to no effect on KDQOL symptoms/problem list, pain, and physical health and moderate certainty that MCO dialysis likely has no effect on the KDQOL mental health composite.
Conclusions:
We found with predominantly moderate certainty that the MCO dialyzer improves several patient-important outcomes with no apparent risks or harms. More definitive studies are needed to better quantify the effects of MCO membranes on mortality, hospitalization, and other rare events.
The objective of the study was to develop an inventory summarizing all anchor-based minimal important difference (MID) estimates for patient-reported outcome measures (PROMs) available in the medical ...literature.
We searched MEDLINE, EMBASE, CINAHL, PsycINFO, and the Patient-Reported Outcome and Quality of Life Instruments Database internal library (January 1989–October 2018). We included primary studies empirically calculating an anchor-based MID estimate for any PROM in adults and adolescents. Pairs of reviewers independently screened and selected studies, extracted data, and evaluated the credibility of the MIDs.
We identified 585 eligible studies, the majority conducted in Europe (n = 211) and North America (n = 179), reporting 5,324 MID estimates for 526 distinct PROMs. Investigators conducted their studies in the context of patients receiving surgical (n = 105, 18%), pharmacological (n = 85, 15%), rehabilitation (n = 65, 11%), or a combination of interventions (n = 194, 33%). Of all MID estimates, 59% (n = 3,131) used a global rating of change anchor. Major credibility limitations included weak correlation (n = 1,246, 23%) or no information regarding the correlation (n = 3,498, 66%) between the PROM and anchor and imprecision in the MID estimate (n = 2,513, 47%).
A large number of MIDs for assisting in the interpretation of PROMs exist. The MID inventory will facilitate the use of MID estimates to inform the interpretation of the magnitude of treatment effects in clinical research and guideline development.
Buttonhole (constant-site) cannulation (BHC) continues to gain popularity with home and in-center dialysis programs worldwide. However, long-term safety data are lacking. This paper reports the ...authors' single-center experience with Staphylococcus aureus bacteremia (SAB) and the efficacy of topical mupirocin prophylaxis (MP).
This study was a retrospective prepost comparison of SAB rates after establishing MP. Fifty-six consecutive patients on home nocturnal hemodialysis via arteriovenous fistulae, mean age 51.5 +/- 10.6 years, 38% women, and vintage 44.5 +/- 34.5 months were observed for a total of 93.4 (pre-MP) and 193.5 (post-MP) patient-years.
Ten episodes of SAB were observed, with metastatic complications in four cases, including pneumonia (n = 2), septic arthritis, and a fatal C3 epidural abscess. When analyzed by observation period, the odds ratio (OR) for SAB before versus after the introduction of MP was 6.4 95% confidence interval (CI) = 1.3 to 32.3; P = 0.02. Two SAB episodes occurred after the MP started. Both patients had discontinued the MP for 3 weeks (nonadherent) preceding infection; hence, no SAB episodes were observed on treatment. In an as-treated analysis, the OR for SAB in the absence of MP was 35.3 (95% CI = 2.0 to 626.7; P = 0.01).
BHC is associated with a significant risk of SAB with metastatic complications. In this prepost comparison of SAB rates, no infections were observed with MP. While awaiting more definitive studies, this simple intervention should be considered for patients using BHC.
Patients undergoing conventional maintenance hemodialysis typically receive three sessions per week, each lasting 2.5-5.5 hours. Recently, the use of more intensive hemodialysis (>5.5 hours, three to ...seven times per week) has increased, but the effects of these regimens on survival are uncertain. We conducted a retrospective cohort study to examine whether intensive hemodialysis associates with better survival than conventional hemodialysis. We identified 420 patients in the International Quotidian Dialysis Registry who received intensive home hemodialysis in France, the United States, and Canada between January 2000 and August 2010. We matched 338 of these patients to 1388 patients in the Dialysis Outcomes and Practice Patterns Study who received in-center conventional hemodialysis during the same time period by country, ESRD duration, and propensity score. The intensive hemodialysis group received a mean (SD) 4.8 (1.1) sessions per week with a mean treatment time of 7.4 (0.87) hours per session; the conventional group received three sessions per week with a mean treatment time of 3.9 (0.32) hours per session. During 3008 patient-years of follow-up, 45 (13%) of 338 patients receiving intensive hemodialysis died compared with 293 (21%) of 1388 patients receiving conventional hemodialysis (6.1 versus 10.5 deaths per 100 person-years; hazard ratio, 0.55 95% confidence interval, 0.34-0.87). The strength and direction of the observed association between intensive hemodialysis and improved survival were consistent across all prespecified subgroups and sensitivity analyses. In conclusion, there is a strong association between intensive home hemodialysis and improved survival, but whether this relationship is causal remains unknown.
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